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27

Apr

US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing

Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

Eric Twum, a regulatory specialist for the Division of Quality II in the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER), shared these insights on the QMM pilot at the Generic Drugs Forum held online and in White Oak, MD, on 22 April....[RAPS]

08

Mag

Farmaceutica, Gemmato: 'per Testo unico deadline entro dicembre'

"Il Testo unico sulla legislazione farmaceutica, che ha come obiettivo quello compendiare 800 fra...

08

Mag

Min. Salute Gemmato: “Testo unico farmaceutico entro dicembre 2026”

Il sottosegretario alla Salute indica la tabella di marcia della riforma. Al centro accesso ai farmaci...

08

Mag

Precursori droghe: controllo esteso a 9 nuove sostanze dal 18 settembre 2026

Regolamento delegato (UE) 2026/314 della Commissione del 9 febbraio 2026 recante modifica del regolamento...

08

Mag

US FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

The U.S. Food and Drug Administration (FDA) on Wednesday unveiled a one-day inspectional assessment...

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